Two recent decisions by the BBB National Programs' National Advertising Division (NAD) have brought renewed attention to the substantiation of advertising claims in the dietary supplement industry. The rulings on Olly PBC’s Kids Chillax product and Ingenuity’s BrainPack Daily Adult Gummy Vitamins underscored the rigorous standards required to support express and implied claims and the evolving role of consumer reviews in regulatory scrutiny.
We spoke to Asa Waldstein, principal of the consulting company Supplement Advisory Group, and Jennifer Adams, attorney at Amin Wasserman Gurnani, who weighed in on the implications of these cases for nutrition and dietary supplement manufacturers and suppliers.
Olly Kids Chillax: Evaluating calm and relaxation claims
In a challenge brought by Bayer Healthcare LLC, NAD reviewed Olly PBC’s claims that its Kids Chillax supplement “supports a calm and relaxed mood” and that its key ingredient, L-theanine, “works within 60 minutes to support a relaxed state of mind,” according to the organization’s recently published case decision summary.
NAD determined that Olly’s clinical study was “not a good fit for the challenged express claims because, among other reasons, NAD found that the assessments used to assess anxiety levels in the study were not reliable for the youngest participants in the study.”
Furthermore, NAD found that “the evidence provided on L-theanine did not provide a good fit for the challenged claims.”
NAD recommended that Olly discontinue or modify the following claims:
- Kids Chillax “supports a calm and relaxed mood”
- “Z is for Zen: These peaceful pals are just the thing to help gently calm little minds, while helping kiddos stay engaged”
L-Theanine is “Captain calm” - A 50 mg dose of L-theanine “works within 60 minutes to support a relaxed state of mind”
- L-theanine “helps support a calm mood for kiddos”
- L-theanine “works to support a relaxed state of mind”
An Olly spokesperson told NutraIngredients that the company will appeal part of NAD’s decision.
“Olly is a strong supporter of advertising self-regulation and appreciates NAD’s determination that Olly is engaged in reasonable practices with respect to the collection of third party reviews,” the spokesperson said.
“Olly respectfully disagrees with NAD’s recommendations that it discontinue or modify the claims for its Kids Chillax product and will appeal those portions of the decision to the NARB.”
The appeal will be reviewed by the BBB National Programs' National Advertising Review Board (NARB), the appellate-level truth-in-advertising body, NAD confirmed.
“We don’t have access to Olly’s study details, but it seems that NAD took issue with its design, as they determined that the methods used to evaluate anxiety levels in the study were apparently not reliable for the youngest participants,” Waldstein said. This accentuates the broader challenge supplement manufacturers face when substantiating claims with clinical evidence, particularly for children’s products.
Adams also provided insight into the review aspect of the case.
“NAD is echoing FTC’s position that reviews do not necessarily need to be removed, even with unsupported claims, so long as they are real and not derived from any misleading advertising,” she explained.
“Consumer review moderation for FDA and FTC compliance considerations can be a double-edged sword, as removing noncompliant or unsubstantiated content can look good to regulators, but too much involvement can cause a company to lose some immunities available to online posting forums under the CDA.”
As a result she said that NAD’s decision, especially given the disease claim implications, is a key precedent, noting that “companies can maintain a balance between authentic reviews and legal and advertising compliance.”
The role of consumer reviews in advertising claims
Bayer also challenged consumer reviews on Olly’s website, arguing that they conveyed an implied message that Kids Chillax could help with ADHD, behavioral problems, anxiety and sleep troubles, NAD’s case decision reported.
However, the organization found that “the reviews are authentic because there was no evidence in the record that the reviews were false or fake, or that the reviews misrepresented or were not reflective of the individual reviewer’s experience.”
NAD emphasized that while Federal Trade Commission (FTC) guidance does not require advertisers to moderate reviews with unsupported product claims, brands should “monitor independent reviews for misleading messages.”
If a misleading message is repeated, NAD suggested that advertisers “consider (1) removing reviews that make unsupported product claims (positive or negative), and (2) examine its advertising to determine if it contributes to misleading messages.”
Waldstein highlighted the significance of this finding.
“The most interesting takeaway from this case concerns product reviews... The challenging company, Bayer, argued that Olly’s website consumer reviews were misleading and should be removed... NAD determined the reviews were authentic and that Olly’s review collection practices were reasonable,” he said.
“This is an important nuance because filtering out negative reviews or encouraging consumers solely to post positive reviews is not allowable and can lead to expensive repercussions, as we see in this FTC Fashion Nova $2.4 million decision.”
BrainPack Daily Adult Gummy Vitamins: Cognitive claims scrutinized
In a separate case, NAD reviewed claims made for BrainPack Daily Adult Gummy Vitamins, including “Memory”, “Clarity”, “Focus” and “Vision”.
NAD determined that “one reasonable message conveyed by the label claims was that the BrainPack Daily Adult Gummy Vitamins product would improve cognitive performance in a measurable way, a claim that was not supported by the record,” according to its recently published case decision summary.
Consequently, NAD recommended that the claims be discontinued or modified to avoid overstating the benefits of the vitamins.
Ingenuity, the manufacturer of BrainPack, stated that while it “disagrees with elements of the NAD’s analysis, it agrees to comply with NAD’s recommendations.” Ingenuity did not respond to NutraIngredient’s request for comment regarding the NAD’s decision prior to publication.
“Nutrient-based structure/function claims pose an interesting substantiation situation,” Adams said, as “the everyday function of essential nutrients in the body is widely accepted in the scientific community and generally isn’t being studied in interventional trials—for example, calcium for bone health.”
“These types of claims frequently meet the CARSE standard without a double-blind, placebo-controlled trial, but the claim’s language must be clearly tailored to this everyday health benefit, otherwise it may need interventional data to be adequately supported.”
Waldstein echoed Adams' emphasis on the importance of clearly tailored claim language: “The narrower the claim, the more substantiation is needed.” For example, he illustrated, “using strong action words like ‘promote’ can raise the level of substantiation required.”
He advised that as “even small words can impact the amount of substantiation needed,” it can be beneficial for brands to take steps toward creating a ‘company culture of compliance.’ By supporting marketing, sales, regulatory, and social teams in understanding “the guardrails of substantiation,” he concluded, brands can ensure marketing claims will be followed to help avoid potential regulatory intervention.
